FEATURES
Customized Clinical Research Solutions
THE STORY
The National Institute of Environmental Health Sciences (NIEHS) is conducting clinical research to study impacts of environmental agents on human health, including both observational clinical research studies and interventional clinical trials.
For the NIEHS Clinical Research Support Contract, SRA provides comprehensive research assistance in areas such as study design; preparation of study documents and data collection forms; human subjects protection; IRB submissions, development and administration of study training; all aspects of study implementation and monitoring; data management; data privacy and security; biostatistical analysis; and bioinfomatics support; publication support.
RESULTS
While SRA has a standard package of tools, we can customize our services and solutions specifically to meet the client’s needs. We are flexible while still meeting regulatory standards as well as IRB, HIPAA and OMB regulations. This allows us to provide quality solutions that specifically meet customer needs. Customer satisfaction is at the core of our work.
Challenges
- Implement an asthma intervention study in children in post-Katrina New Orleans
- Develop a national recruitment strategy to assess participant eligibility for a study to be conducted at a single clinical site.
- Conduct local in-home allergen reduction study with a behavioral intervention
Outcome
- Closely engaged local public health organizations and academic institutions in study design and implementation
- Collaborated with a national home health network to conduct all initial screening visits at participants’ homes around the country
- Developed effective recruitment efforts and excellent rapport with participants which resulted in 92% retention throughout the study
EXPERTISE
- Develop creative study implementation strategies
- Adhere to rigorous scientific methods
- Navigate complex regulatory processes
- Ensure data security and patient confidentiality
- Enthusiastic staff with deep domain expertise
- Exemplary recruiting and follow-up success through rapport with study participants
- Advanced participant tracing methods to reduce loss-to-follow up
- Customized or off-the-shelf IT solutions for data collection, management, and analysis
- Strong environmental health and clinical research experience
- Collecting and reporting of safety data
- Solid statistical and bioinformatics expertise
RELATED INFO
SRA supplies the people, expertise, and tools to support Government sponsors in development and implementation of observational and interventional clinical studies. We can help determine how chemical and environmental exposures may influence a variety of diseases, and we implement research with new interventions to improve public health.
Services
- Study design, management and implementation
- Data collection and management
- Statistical analysis
Careers | Find a Career
- Project Manager / Public Health Study Manager
- Data Manager
- Biostatistician/Bioinformatician
